Self-administered topical 5% imiquimod cream for external anogenital warts
Self-administered topical 5% imiquimod cream for external anogenital warts
复制标题
DOI：
10.1001/archderm.134.1.25
复制
发表时间：
1998-01-01
影响因子：
--
通讯作者：
Schmitt, KA
中科院分区：
文献类型：
--
作者：
Edwards, L;Ferenczy, A;Schmitt, KA
目的：比较5%、1%咪喹莫特乳膏与载体乳膏治疗外生殖器疣的安全性和有效性。设计：随机、双盲、安慰剂对照比较，评估患者疣的完全清除情况。在12周的随访中评估完全清除的患者的复发情况。环境：11个流动办公室，包括私人医生办公室和转诊医疗中心。患者：311名年龄在18岁或以上，伴有2 - 50个外生殖器疣的健康男性和女性被从调查者、转诊医生和广告中招募。另外82名患者接受了筛查，但不符合条件。四名患者因副作用停止使用该药。干预措施：将5%咪喹莫特（Aldara）乳膏、1%咪喹莫特乳膏或替代乳膏涂于所有外部疣体上，每周3次，持续16周，或直至所有治疗过的疣体消失，以先发生者为准。主要结果测量：所有基线疣消除的患者数量和这些疣的复发率。此外，基线疣面积的减少、消除疣所需的治疗时间以及不良反应的频率和严重程度是主要的测量指标。结果：在意向治疗分析中，109例接受5%咪喹莫特乳膏的患者中有54例（50%），102例接受1%咪喹莫特乳膏的患者中有21例（21%），100例接受辅助乳膏的患者中有11例（11%）的基线疣被根除。5%咪喹莫特乳膏与载体乳膏的疗效差异有统计学意义(P
Objective: To compare the safety and effectiveness of 5% and 1% imiquimod cream with vehicle cream in the treatment of external anogenital warts.Design: Randomized, double-blind, placebo-controlled comparison that evaluated patients for total clearance of their warts. Patients who experienced total clearance were evaluated for recurrence in a 12-week follow-up.Setting: Eleven ambulatory offices, including both private physician offices and referral medical centers.Patients: Three hundred eleven healthy men and women aged 18 years or older with 2 to 50 external anogenital warts were recruited from the practices of investigators, referring physicians, and advertisements. Eighty-two additional patients were screened but did not qualify. Four patients discontinued use of the medication because of adverse effects.Interventions: Five percent imiquimod (Aldara) cream, 1% imiquimod cream, or vehicle cream was applied to all external warts overnight 3 times each week for 16 weeks, or until all treated warts disappeared, whichever occurred first.Main Outcome Measurements: The number of patients experiencing the elimination of all baseline warts andthe recurrence rate of these warts. In addition, the reduction in baseline wart area, the duration of therapy required to eliminate warts, and the frequency and severity of adverse reactions were principal measurements.Results: In the intent-to-treat analysis, 54 (50%) of 109 patients who received 5% imiquimod cream, 21 (21%) of 102 of those who received 1% imiquimod cream, and 11 (11%) of 100 patients treated with vehicle cream experienced eradication of all treated baseline warts. The difference between the effectiveness of 5% imiquimod cream and the vehicle cream was statistically significant (P